NDC 69189-5820

Tikosyn

Dofetilide

Tikosyn is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Dofetilide.

• Product ID: 69189-5820_7c329776-808b-4c94-a77b-3c0d403917b6
• NDC: 69189-5820
• Product Type: Human Prescription Drug
• Proprietary Name: Tikosyn
• Generic Name: Dofetilide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2016-03-28
• Marketing Category: NDA / NDA
• Application Number: NDA020931
• Labeler Name: Avera McKennan Hospital
• Substance Name: DOFETILIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Antiarrhythmic [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 69189-5820-1

1 CAPSULE in 1 DOSE PACK (69189-5820-1)

• Marketing Start Date: 2016-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69189-5820-1 [69189582001]

Tikosyn CAPSULE

• Marketing Category: NDA
• Application Number: NDA020931
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-03-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DOFETILIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: b77b4388-36ec-4971-90a5-353879adb8b5
• Manufacturer:
  • Avera McKennan Hospital
• UNII:
  • R4Z9X1N2ND
• RxNorm Concept Unique ID - RxCUI:
  • 285016
  • 310005

Pharmacological Class

• Antiarrhythmic [EPC]

NDC Crossover Matching brand name "Tikosyn" or generic name "Dofetilide"

NDC	Brand Name	Generic Name
0069-5800	Tikosyn	dofetilide
0069-5810	Tikosyn	dofetilide
0069-5820	Tikosyn	dofetilide
69189-5800	Tikosyn	Tikosyn
69189-5810	Tikosyn	Tikosyn
69189-5820	Tikosyn	Tikosyn
0904-6681	Dofetilide	Dofetilide
0904-6682	Dofetilide	Dofetilide
0904-6683	Dofetilide	Dofetilide
16714-840	Dofetilide	Dofetilide
16714-841	Dofetilide	Dofetilide
16714-842	Dofetilide	Dofetilide
16729-490	Dofetilide	Dofetilide
16729-491	Dofetilide	Dofetilide
16729-492	Dofetilide	Dofetilide
42291-411	Dofetilide	Dofetilide
42291-412	Dofetilide	Dofetilide
42291-413	Dofetilide	Dofetilide